Evaluation of the Agili-C Biphasic Implant in the Knee Joint
The purpose of this study is to determine the performance of the Agili-C implants. The study hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and cartilage-bone joint surface defects.
Device: Agili-C Bi-phasic Implant
Procedure: mini-arthrotomy or arthroscopy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects|
- improvement in KOOS pain subscales [ Time Frame: 24 months ] [ Designated as safety issue: No ]The primary efficacy endpoint for this trial will be the change from baseline up to 24 months visit in pain score as measured by the KOOS pain subscale
- KOOS total score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Change from baseline to 3, 6, 9, 12, 18 and 24 months visits as measured by the KOOS total score and subscales.
- Change from baseline to 18 and 24 months visit in IKDC current health assessment.
- Change from baseline to 3, 6, 12, 18 and 24 months visit in Lysholm with Tegner knee score.
- Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC knee examination form 2000
- Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC subjective knee evaluation
- Change in MOCART scoring as measured at 3, 6, 12 , 18 and 24 months visit
- number of SAE [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Complications and adverse events, device-related or not, will be evaluated over the course of the clinical trial, including subsequent surgical interventions
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Agili-c bi-phasic implant
mini-arthrotomy or arthroscopy
Device: Agili-C Bi-phasic Implant
The implantation site should be created in perpendicular manner to the articular cartilage. The surrounding tissue will be cleaned and scraped to prepare a clean site. The implant will be placed in the correct orientation (drilled channels pointing towards the joint side and chamfer towards the bone).
The implant will be inserted gently in a pressed fit manner.
Other Name: Agili-C implantProcedure: mini-arthrotomy or arthroscopy
The procedure will be conducted according to hospital practice. The implants will be positioned via arthroscopy or open incision, depending on lesion location, and Investigator`s final decision. Related treatments during the procedure should be recorded.
Device positioning details medications and adverse events during the procedure will be recorded. MOCART (off-site), X-ray evaluation (off-site), ICRS Cartilage injury mapping system, Articular cartilage injury Classification and the Osteochondritis Dissecans classification will be recorded.
Agili-C implant is a bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of focal articular cartilage and for osteochondral defects. Up to 50 patients are to be included in the study. Patients suffering from isolated, single and focal cartilage or osteochondral defect at the knee joint are considered for study inclusion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471236
|Clinical Hospital ''Sveti Duh''|
|Fakultní nemocnice Brno|
|Brno, Czech Republic|
|Uzsoki Street Hospital|
|Rizzoli Orthopaedic Institute|
|County Hospital of Timisoara,|
|Timisoara, Romania, 300203|
|Institut za Ortopedsko-hirurške|
|Clinical center of Vojvodina|
|Novi Sad, Serbia|
|Principal Investigator:||Elizaveta Kon, MD|